Senior Statistical Programmer | Clinical Trials Lead

Cytel; City of Albany (NY); On-site; USD 140,000 - 195,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer who will be dedicated to a pharmaceutical client. This role involves independent work with minimal supervision, providing expert SAS programming and leadership for complex clinical trial analyses and regulatory submissions.

The successful candidate will guide SDTM/ADaM data structures, Define.xml, and CDISC submissions, while collaborating with IS, CROs, and regulatory authorities to ensure audit-ready results.

Qualifications

• MS in biostatistics or related field with 8+ years in pharma.
• BS in biostatistics or related field with 10+ years in pharma.
• Exceptional SAS programming skills and clinical data analysis expertise.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Regulatory submissions experience with FDA/ICH; ability to interact with regulators.
• Ability to work independently and lead projects/sub-teams.
• Excellent written and verbal communication and leadership skills.
• Experience with regulatory submissions (BLAs/MAAs) is a plus.

Responsibilities

• Lead SAS programs for Tables, Listings and Figures and CDISC data submissions.
• Create, review, and approve documentation for data analysis and CDISC submission.
• Ensure compliance with SOPs and FDA/ICH regulations.
• Lead technical meetings with internal and external partners (IS, CROs, vendors).
• Perform QC of advanced SAS code for datasets and outputs.
• Review Define.xml and create reviewers guide for SDTM/ADaM datasets.
• Maintain study documents per standard processes.
• Program, test, and document global utility programs and tools.
• Perform other duties as assigned.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulatory knowledge

Statistical programming leadership

Independent work

Communication & leadership

Regulatory submissions experience

Education

MS in biostatistics or related field

BS in biostatistics or related field

Tools

BASE SAS

SAS/STAT

SAS/GRAPH

SAS Macro language

Define.xml tooling

CDISC concepts

Job description

Cytel is seeking a Principal Statistical Programmer who will be dedicated to a pharmaceutical client. This role involves independent work with minimal supervision, providing expert SAS programming and leadership for complex clinical trial analyses and regulatory submissions.

The successful candidate will guide SDTM/ADaM data structures, Define.xml, and CDISC submissions, while collaborating with IS, CROs, and regulatory authorities to ensure audit-ready results.